UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002191 |
|---|---|
| Receipt number | R000002072 |
| Scientific Title | A randomized double-blind controlled study to assess the safety and efficacy of carbon dioxide insufflation during endoscopic submucosal dissection for large superficial colorectal neoplasms |
| Date of disclosure of the study information | 2009/07/13 |
| Last modified on | 2009/07/13 15:56:03 |
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Basic information
Public title
A randomized double-blind controlled study to assess the safety and efficacy of carbon dioxide insufflation during endoscopic submucosal dissection for large superficial colorectal neoplasms
Acronym
A randomized double-blind controlled study of carbon dioxide insufflation during endoscopic submucosal dissection for large superficial colorectal neoplasms
Scientific Title
A randomized double-blind controlled study to assess the safety and efficacy of carbon dioxide insufflation during endoscopic submucosal dissection for large superficial colorectal neoplasms
Scientific Title:Acronym
A randomized double-blind controlled study of carbon dioxide insufflation during endoscopic submucosal dissection for large superficial colorectal neoplasms
Region
| Japan |
Condition
Condition
large superficial colorectal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the safety and efficacy of carbon dioxide insufflation during endoscopic submucosal dissection for large superficial colorectal neoplasms.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of en-bloc resection.
The mean operation time.
The score of abdominal distension and pain immediately and 1 hour after the procedure.
Key secondary outcomes
The rate of complication.
The amount of sedative administered during the procedure.
The amounts of gas in the intestine, immediately and 1 hour after the procedure.
difference of the abdominal circumference before and immediately after the procedure.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
To assess the influence of the air insufflation to the success rate of colorectal ESD and the patient's discomfort during the procedure, and the association of harmful events.
The study period will be from approval until 31 March 2010.
Interventions/Control_2
To assess the influence of the carbon dioxide insufflation to the success rate of colorectal ESD and the patient's discomfort during the procedure, and the association of harmful events.
The study period will be from approval until 31 March 2010.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with superficial colorectal tumor larger than 2cm.
Key exclusion criteria
Patients for whom colorectal tumor resection cannot be expected to improve survival prognosis due to serious underlying disease (advanced cancer, severe infection, serious respiratory disease or cardiovascular disease)
Patients who are under age or have dementia, or who cannot grant informed consent themselves for some other comparable reason.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohiko Miyata |
Organization
Jichi Medical University
Division name
Endoscopy center
Zip code
Address
3311-1, yakushiji, shimotuke-shi, tochigi pref. Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Jichi Medical University
Division name
Endoscopy center
Zip code
Address
TEL
Homepage URL
s2k@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Fuji Film Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 07 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Date of protocol fixation
| 2009 | Year | 07 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 07 | Month | 13 | Day |
Last modified on
| 2009 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002072
